Abstract 587P
Background
This Phase 4 study was conducted with Biocon’s biosimilar bevacizumab to evaluate its safety and tolerability when administered as an intravenous (IV) infusion, as per the prescribing information (PI).
Methods
This multicenter, single-arm, open-label, Phase 4 study assessed 225 patients (mean age, 53.39 years) with solid tumors (ovarian [n=112], colorectal [n=67], cervical [n=18], glioblastoma [n=17], non-small cell lung [n=10], and renal cancer [n=1]) at 20 sites in India from Nov 2019 to Sep 2021. Patients received 5-15 mg/kg body weight of biosimilar bevacizumab IV infusion once every 2/3 weeks based on the indication and as per the PI, up to a maximum of 6 months or until disease progression or unacceptable toxicity, whichever was earlier. The incidence, nature, and severity of adverse events (AEs) causally related to biosimilar bevacizumab were assessed and classified using Common Terminology Criteria for Adverse Events, v4.03.
Results
Overall, 383 AEs were reported in 136 patients in the study. The majority of the AEs (244) were mild (Grade 1) and 65 were ≥ Grade 3 in intensity. A total of 316 AEs recovered/resolved, and the majority of the AEs (314 AEs) were unrelated to biosimilar bevacizumab on evaluation. Study treatment was discontinued in 18 patients due to AEs, and 21 patients had radiological progression. There were 61 serious AEs (SAEs), of which 15 were fatal and only 6 were considered at least possibly related to the study drug. The drug was well tolerated and no new safety concerns were observed. The most common adverse events reported in ≥ 5% of patients were weight loss (10.2%), vomiting (9.3%), nausea (8.9%), asthenia (8.4%), anaemia (8%), thrombocytopenia (6.2%), constipation (5.8%), and neutropenia (5.3%).
Conclusions
Biosimilar bevacizumab was well tolerated when administered to patients with solid tumors treated as per the PI, and no significant safety concerns were observed. Overall, the nature of the reported AEs in this study is in line with the safety profile of bevacizumab.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
Biocon Biologics Ltd.
Funding
Biocon Biologics Ltd.
Disclosure
K.H. Upveja, S. Deodhar, R. Kapur: Financial Interests, Institutional, Full or part-time Employment: Biocon Biologics Ltd. All other authors have declared no conflicts of interest.